Validation Lead

Responsibilities

• Lead and coordinate verification work for equipment, processes, and computer systems
• Perform risk analyses (FMEA, HACCP) and develop verification strategies
• Plan, review, create, and approve verification documentation including URS, commissioning, DQ, IQ, OQ, and PQ
• Create test protocols for verification testing
• Ensure validation activities comply with regulatory requirements (GMP, FDA, ISO standards)
• Collaborate with customers and project teams to ensure timelines and project goals are met

Requirements

• Engineering degree in biotechnology, medical technology, chemical engineering, mechanical engineering, or equivalent
• Experience in a validation/qualification role within Life Science production
• Experience and knowledge of GAMP5 and system classification
• Strong knowledge of regulatory requirements and standards such as GMP, EudraLex Volume 4 Annex 15, and ISO 13485
• Experience creating and reviewing validation documentation (URS, DQ, IQ, OQ, PQ)
• Knowledge of risk analysis methods like FMEA
• Fluency in Swedish and English, both written and spoken

About the Company

Knightec Group is one of Northern Europe's leading strategic partners in product and digital service development, helping customers transform new technology into real-world solutions.